As a result of the COVID-19 pandemic the medical device and pharmaceutical industries have experienced an exponential surge in demand for supply of pharmaceuticals and medical devices. Allied to this is the pioneering work Irish based companies and universities are doing to support the development of new technologies to help bring the COVID-19 pandemic to an end. We explore key national and European regulatory measures that have enabled the approval procedure for and importation of pharmaceuticals and medical devices to be accelerated so that the demand emanating from this global health crisis can be met.
Regulatory Flexibility on Medicines
To assist with the evolving status of the pandemic and the pressures it creates, the European Commission (EC), the Coordination group for Mutual Recognition and Decentralised Procedures – human (CMDh) and the European Medicines Agency (EMA) have published a helpful Q&A document.
The Q&A document:
- Provides a one-stop shop for guidance to marketing authorisation holders of medicinal products for human use (MAH) on regulatory expectations and flexibility during the COVID-19 pandemic.
- Outlines new measures introduced for various areas including marketing authorisations, manufacturing and importation of finished products and active pharmaceutical ingredients, quality variations and product information and labelling.
Some of the key regulatory changes include:
- To ensure continuity of supply of medicinal products intended for use in COVID-19 patients the CMDh has agreed to promote the use of zero-day mutual recognition procedure/repeat use procedure to expand national marketing authorisations to new Member States who need these medicinal products.
- Member States may also authorise a medicinal product that has already been authorised in another EU Member State.
- In cases where no centralised/relevant national marketing authorisation exists, Member States may temporarily authorise the distribution of an unauthorised medicinal product or authorise a medicinal product on compassionate grounds in line with requirements in the various relevant EU Directives and Regulations.
- To reduce the risk of shortages or disruption of crucial medicines for treatment of COVID-19 patients, an exceptional change management process (ECMP) has been set up for MAHs of such medicines. Typically, only suppliers specifically mentioned in the marketing authorisation can be used by the manufacturer. During the crisis, the ECMP will sanction changes to suppliers and/or manufacturing/control sites and MAHs will be permitted to source starting materials, reagents, intermediates or active substances from suppliers not specifically mentioned in the marketing authorisation, while deferring the full assessment of the variation application.
- Where there are severe problems of availability of a medicinal product in a Member State the packaging of a product need not be in the official language of the Member State in which the medicinal product is being used. Furthermore, it is acceptable if the presentation of the packaging/labelling differs from the presentations authorised in the Member State where the product is marketed.
Regulatory Flexibility on Medical Devices
Approval of Non-CE marked medical devices in Ireland
Medical devices must be approved by a notified body and bear a CE Mark prior to being put on the market in the EU and EEA. However, to ensure supply of critical medical devices the HPRA has introduced a regulatory derogation in respect of non-CE marked medical devices in Ireland.
This derogation is noteworthy and to be welcomed as hand sanitisers, face masks and personal protective equipment are all products which are in high demand and affected by this regulatory circumvention.
The HPRA has developed a process for the urgent assessment of applications to use non-CE marked medical devices in Ireland. The HPRA assesses these devices to determine whether the provision of non-CE marked devices is in the interest of the protection of health. Further information on how to apply for this derogation is available here.
European Commission Guidance for Medical Devices in the Context of COVID-19
Similar to the Q&A document for medicines the EC has recently published guidance on medical devices, active implantable medical devices and in-vitro diagnostic medical devices in the context of COVID-19.
This document provides helpful guidance on the legal requirements for placing medical devices on the market and compliance verification, use and source of appropriate standards, derogation process and the Commission’s suggested considerations, registration and off-label use. The harmonised standards most relevant for the public health crisis associated to the COVID-19 outbreak are at annex 1 to the Q&A document.
Postponement of EU Medical Device Regulation
Solution based approaches like this are well received within the industry. Support surrounding the deferral of the Medical Devices Regulation’s implementation date was previously discussed here. The European Commission has since submitted its one-year postponement proposal and the new date of application is proposed as 26 May 2021. This is a welcome development as it seeks to alleviate the regulatory burden medical device suppliers face in these unprecedented times. On 20 April 2020 the European Parliament and Council agreed on the final text of the Regulation; it therefore appears the postponement will proceed. We await their final approval which is expected at the end of the month.
COVID-19 Related Human Research – Expedited Regulatory and Ethical Review
The HPRA, in conjunction with the Department of Health, the National Office for Research Ethics Committees and the Health Research Declaration Committee (HRCDC), have agreed an expedited review process for human health research related to COVID-19.
The most recent and key development in this regard comes with the Minister for Health’s establishment of a specialised COVID-19 National Research Ethics Committee (NREC-COVID-19). This committee is designed to ensure cooperation between bodies involved in regulation of health research including the HPRA and the HRCDC. The stated ambition of the NREC-COVID-19 is to relay decisions back to researchers within 7 days of confirmation of a validated application.
The NREC-COVID-19 will review all COVID-19-related studies that fall under the definition of health research as set out in the Health Research Regulations 2018.
Revenue Commissioners’ Flexibility
Critical pharmaceutical products
During the crisis, critical pharmaceutical products and medicines will be given a customs “green” routing status. “Green” routing means that no examination of the goods or supporting documentation is required. This ensures that the importation and supply to health care professionals and medical stations is uninterrupted.
Relief from the payment of import duties and VAT for goods imported to combat COVID-19
Revenue has confirmed that it has implemented an EU Commission decision that allows goods to combat COVID-19 to be imported, from outside the EU, free of import duties and VAT. This 6-month relief measure is available to approved organisations which include State organisations and charities and businesses importing on their behalf and organisations approved by Revenue (including those regulated by the State and involved in the care, support and treatment of people at risk of COVID-19). The relief although welcome is somewhat restrictive, as the organisations must use the goods for COVID-19 purposes and make them available to people at risk, free of charge.
Unified Approach of Regulators to COVID-19
All hands are on deck from a regulatory perspective to support healthcare and life sciences industries’ supply medicines and medical devices both nationally and on a global scale. Accommodations made by regulators during this period of uncertainty are to be applauded and it is hoped that they will ultimately assist in overcoming COVID-19.
If you have any specific queries in relation to the COVID-19 and your business, please get in touch with your regular William Fry contact. We also have a specific COVID-19 Hub to assist you.